Clinical Evidence

How we measure performance.

Histolyx is designed for workflow acceleration — not autonomous diagnosis. Our performance data reflects workflow metrics collected during internal testing and early deployments. We do not cherry-pick optimal-condition benchmarks or claim published sensitivity/specificity numbers without peer-reviewed context.

Workflow metrics

Internal benchmarks — workflow performance only.

These numbers reflect internal testing on retrospective data. They measure workflow speed, not clinical sensitivity. Radiologists reviewing Histolyx output retain full diagnostic responsibility.

<90s Average study analysis time Measured on chest CT dataset, standard clinical study sizes. Network transfer time not included.
94% Annotation agreement rate with radiologist review Blinded retrospective review: radiologist findings vs. Histolyx-flagged candidates, chest CT subset. Internal dataset.
38% Reduction in time-to-first-flag vs. unaided read Measured across timed read sessions in internal study. Subject to individual radiologist variance. Not generalizable without external validation.
600+ Studies pre-read per day in active deployments Aggregate across current pilot deployments. Volume continues to grow with deployment expansion.

How we measure

Performance data for Histolyx is collected from internal retrospective studies using de-identified imaging datasets. All studies are conducted at Histolyx under blinded review protocols: radiologists review studies without knowledge of Histolyx's output, and Histolyx's output is evaluated against radiologist findings as the reference standard.

We do not use published benchmark datasets such as LUNA16 or CBIS-DDSM as primary performance claims — those datasets have value for model development, but performance on a curated benchmark tells you little about how a pre-reader behaves on routine clinical studies from your scanner. Our internal datasets include studies across multiple scanner manufacturers, field strengths, and acquisition protocols to better reflect actual deployment variability.

Histolyx entered early deployments in 2025 and is accumulating real-world workflow data. There are no published peer-reviewed studies of Histolyx at this time. When peer-reviewed data is available, it will be linked from this page. We will not claim peer-reviewed performance without providing the citation.

Important: Histolyx is designed as a decision support tool for trained radiology and pathology professionals. It is not intended to replace clinical judgment, and all diagnostic conclusions require radiologist or pathologist review and sign-off. Histolyx does not have FDA 510(k) clearance or De Novo authorization. It is not designed as a standalone diagnostic device. Radiologists retain full clinical and legal responsibility for all diagnostic conclusions made using studies pre-read by Histolyx.